Apparatus and methods for sealing a vascular puncture

ABSTRACT

An apparatus for sealing a puncture includes a positioning member including a proximal end, a distal end sized for insertion into a puncture, an expandable element on the distal end, and a tension indicator on the proximal end. The tension indicator includes a distal housing portion fixed relative to the proximal end, and a proximal housing portion or handle movable proximally relative to the distal housing portion. The handle is biased towards the distal housing portion such that, when sufficient tensile force is applied between the expandable element and the handle, the handle moves away from the distal housing portion. During use, the distal end is introduced through a puncture into a vessel, the expandable element is expanded, and the positioning member is partially withdrawn until the expanded element contacts a wall of the vessel and the handle separates from the distal housing portion, indicating that sufficient tension is applied.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/191,237, filed on Feb. 26, 2014, titled “APPARATUS AND METHODS FORSEALING A VASCULAR PUNCTURE”, which is a continuation-in-part of U.S.patent application Ser. No. 13/252,061, filed on Oct. 3, 2011, titled“APPARATUS AND METHODS FOR SEALING A VASCULAR PUNCTURE”, which is acontinuation-in-part of U.S. patent application Ser. No. 12/098,380,filed on Apr. 4, 2008, titled “APPARATUS AND METHODS FOR SEALING AVASCULAR PUNCTURE”, all of which are incorporated herein by reference intheir entirety.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forsealing punctures in a body, and more particularly, to apparatus andmethods for sealing a vascular puncture extending through tissue into ablood vessel, and to apparatus and methods for delivering a plug,sealant, and/or other material into a percutaneous puncture extendingfrom a patient's skin to a blood vessel or other body lumen, e.g., toseal the puncture.

BACKGROUND

Apparatus and methods are known for accessing a patient's vasculaturepercutaneously, e.g., to perform a procedure within the vasculature, andfor sealing the puncture that results after completing the procedure.For example, a hollow needle may be inserted through a patient's skinand overlying tissue into a blood vessel. A guide wire may be passedthrough the needle lumen into the blood vessel, whereupon the needle maybe removed. An introducer sheath may then be advanced over the guidewire into the vessel, e.g., in conjunction with or subsequent to one ormore dilators.

A catheter or other device may be advanced through the introducer sheathand over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate accessing and/orintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss. Upon completing theprocedure, the device(s) and introducer sheath may be removed, leaving apuncture extending between the skin and the vessel wall.

To seal the puncture, external pressure may be applied to the overlyingtissue, e.g., manually and/or using sandbags, until hemostasis occurs.This procedure, however, may be time consuming and expensive, requiringas much as an hour of a medical professional's time. It is alsouncomfortable for the patient, and may require the patient to remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods for sealing apuncture in a body, and, more particularly, to apparatus and methods forproviding temporary or permanent hemostasis within a vascular punctureextending into a blood vessel, and/or to apparatus and methods fordelivering a sealant and/or other material into a percutaneous punctureextending from a patient's skin to a blood vessel or other body lumen.

In accordance with one embodiment, a system is provided for sealing apuncture extending through tissue that includes an introducer sheath andan elongate positioning or occlusion member. The introducer sheathincludes a lumen and a distal end sized for insertion through apuncture. The elongate positioning member is sized for insertion intothe introducer sheath lumen and includes an expandable element on adistal end of the positioning member and a tension indicator on aproximal end of the positioning member. Optionally, the system mayinclude a sealant cartridge including a tubular member, a sealantdisposed within the tubular member and a pusher member disposed withinthe tubular member for deploying the sealant distally from the tubularmember when the tubular member is retracted proximally relative to thepusher member.

The tension indicator on the proximal end of the positioning memberincludes a proximal housing portion, a distal housing portion and aspring coupled to the proximal housing portion and the distal housingportion. The spring biases the proximal and distal housing portionstogether in a first position yet allows the proximal and distal housingportions to separate to a second extended position, e.g., where thespring is compressed or otherwise directed to a higher potential energystate. For example, a force sufficient to overcome the spring's bias maybe less than a desired tension force applied to the positioning memberduring use, e.g., when the positioning member is pulled to cause theexpandable element in an expanded position to contact a wall of a vesselsufficiently to seal the vessel from the puncture and/or avoid tentingof the wall of the vessel.

In one embodiment, the spring of the tension indicator may extendbetween a spring retaining ring and a shoulder portion of the proximalhousing portion. Further, the spring may be disposed around a hollowcylinder and the hollow cylinder may be coupled to the distal housingportion. The hollow cylinder may be disposed around an internalcylindrical element and the internal cylindrical element and the hollowcylinder may be coupled to the spring retaining ring.

In accordance with another embodiment, an apparatus is provided forproviding temporary hemostasis within a puncture extending throughtissue to a body lumen. The tension indicator apparatus includes anelongate member with a proximal end, a distal end sized for introductioninto a puncture through tissue, an expandable element on the distal end,and a tension indicator on the proximal end. In a collapsed condition,the expandable element is sized for introduction through the punctureinto the body lumen and, in an expanded condition, the expandableelement is larger than the puncture such that the expandable element maybe pulled against a wall of the body lumen adjacent the puncture. Thetension indicator is configured to indicate when sufficient is appliedto the wall when the elongate member is pulled.

In one embodiment, the tension indicator includes a proximal housingportion configured to be held by a user, and a distal housing portion,the proximal and distal housing portions being movable away from oneanother, yet biased to move towards or against one another. For example,a spring, e.g., a compression or extension spring, may be disposedwithin the proximal housing portion for biasing the proximal housingportion towards the distal housing portion. When the spring bias isovercome, the proximal housing portion may move proximally away from thedistal housing portion, thereby creating a space between the proximaland distal housing portions. The space may serve as a visual cue thatthe optimum amount of tension is being applied by the elongate member.The spring may have a spring constant selected such that a tension forcesufficient to overcome the bias of the spring and cause the proximalhousing portion to separate from the distal housing portion maycorrespond to the optimum amount of tension to be applied to providetemporary hemostasis without tenting the vessel wall or pulling thetemporary hemostasis element out of the puncture tract during use. Thus,the spring constant may be selected to apply sufficient force againstthe wall of the body lumen by expandable element to substantially sealthe body lumen from the puncture.

In accordance with still another embodiment, a method is provided forsealing a puncture extending through tissue to a body lumen. The methodincludes introducing an elongate member into the puncture until anexpandable element thereon is disposed within the body lumen, expandingthe expandable element within the body lumen, and retracting theelongate member until the expanded expandable element contacts a wall ofthe body lumen adjacent the puncture and a tension indicator on theelongate member indicates that sufficient tension is applied to the wallof the body lumen by the expandable element to substantially seal thepuncture. Retracting the elongate member may include separating aproximal housing portion of the tension indicator from a distal housingportion of the tension indicator when the desired amount of tension isapplied. In one embodiment, the tension indicator includes a spring andseparating the proximal housing portion from the distal housing portionmay include compressing the spring.

Optionally, the method may include one or more additional steps. Forexample, an introducer sheath may be introduced into the puncture beforeintroducing the elongate member, and the elongate member may beintroduced into the puncture through the introducer sheath. In additionor alternatively, a tubular member or other cartridge carrying a sealanttherein may be advanced along the elongate member and into the puncture,and then retracted to expose the sealant within the puncture. After use,the expandable element may be collapsed, and the elongate member removedfrom the puncture, e.g., through any sealant delivered into thepuncture.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an exemplary embodiment of an apparatusfor delivering a sealant into a puncture through tissue, including acartridge carrying the sealant and a positioning member.

FIG. 1B is an exploded cross-sectional side view of a system fordelivering a sealant into a puncture through tissue, including theapparatus of FIG. 1A (only partially shown) and an introducer sheath.

FIGS. 2A and 2B are cross-sectional views of the apparatus of FIGS. 1Aand 1B, with the cartridge in proximal and distal positions,respectively.

FIGS. 3A and 3B are perspective views of a tension indicator assemblywith a spring in a relatively relaxed state and with the housingattached and with a portion of the housing removed to show internalcomponents, respectively.

FIGS. 4A and 4B are perspective views of the tension indicator assemblyof FIGS. 3A and 3B with the spring in a compressed state and with thehousing attached and a portion of the housing removed, respectively.

FIG. 5 is an exploded perspective view of the tension indicator assemblyof FIGS. 3A-4B.

FIGS. 6A, 7A, 8A, 9A, and 10A are partial cross-sectional side views ofa patient's body illustrating a method of using the system of FIG. 1Bfor sealing a puncture.

FIGS. 6B, 7B, 8B, 9B, and 10B are cross-sectional details of the methodof FIGS. 6A, 7A, 8A, 9A, 10A.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1A and 1B show an exemplary embodiment ofan apparatus 101 and a system 10, respectively, for sealing a puncturethrough tissue. Generally, as shown in FIG. 1A, the apparatus 101includes a cartridge or other tubular member 120, a sealant 2 carried bythe cartridge 120, a plunger, tamping member, or other pusher member 130also carried by the cartridge 120, a cartridge hub 123, a positioning orocclusion member 140, and a positioning member housing 148. As shown inFIG. 1B, the apparatus 101 may be part of a system 10, e.g., which mayalso include a delivery, access, procedure, introducer, or other sheath20. Optionally, the system 10 may include one or more other components,e.g., a needle, guidewire, and/or other instrument(s) for creating apuncture (not shown), and/or a source of additional sealing compound(also not shown), e.g., to provide a kit that may be provided to a user.

As best seen in FIG. 1B, the introducer sheath 20 may be a generallytubular body including a proximal end 22, a distal end 24 sized forinsertion into a puncture through tissue, and a lumen 26 extendingbetween the proximal and distal ends 22 and 24. The introducer sheath 20may be formed from a substantially rigid, semi-rigid, and/or flexibletubular body including a hub 23 on the proximal end 22. The introducersheath 20 may have sufficient length to extend from a patient's skinthrough any intervening tissue into a blood vessel or other body lumen,e.g., having a length between about ten centimeters and twentycentimeters (10-20 cm), and may have an outer diameter between about 1.6millimeters and 4 millimeters (1.6-4 mm). The distal end 24 may betapered and/or may include a substantially atraumatic distal tip 25 forfacilitating advancement through a puncture.

The introducer sheath 20 may be formed using known materials and/ormethods, e.g., plastic with the tubular body and hub 23 substantiallypermanently connected together, e.g., using an interference fit, one ormore mating connectors (not shown), bonding with adhesive, sonicwelding, and the like. The hub 23 generally includes one or more seals(not shown) adjacent an opening 27, which may prevent flow of blood orother fluids out of the hub 23 from the lumen 26, yet accommodateinsertion of one or more instruments into the lumen 26, such as thecartridge 120. Optionally, as shown, the hub 23 may include a side port29 communicating with the lumen 26, e.g., for coupling a source ofsaline or other fluid (not shown) to the hub 23.

With additional reference to FIG. 1B, the cartridge 120 is generally anelongate tubular body including a proximal end 122, a distal end 124sized for introduction into the lumen 26 of the introducer sheath 20,and a lumen 126 extending between the proximal and distal ends 122 and124. The cartridge 120 may be substantially rigid, semi-rigid, orflexible, e.g., such that the cartridge 120 may be advanced through theintroducer sheath 20 or otherwise into a puncture through tissue. Thecartridge 120 may also include a tapered distal tip 125 and/or anenlarged handle or hub 123 on the proximal end 122.

A sealant 2 is provided in the distal portion of the cartridge 120 and apusher member 130 is provided proximal to the sealant 2 within thecartridge 120. The sealant 2 may include a biocompatible, bioabsorbable,and/or expandable material, such as a freeze-dried hydrogel. The sealant2 may have a solid or hollow cylindrical shape, a rolled sheet shape, adisk shape, or other shapes or cross-sections, such as elliptical,triangular, square, conical, disk, or polygonal shapes. For example, thesealant 2 may be formed from a solid material including a lumen 4extending between proximal and distal ends thereof, as shown in FIG. 1B.The lumen 4 may be created by rolling a sheet of material around amandrel, by molding, by boring into or otherwise removing material froman already formed solid material, and the like. The lumen 4 may bedimensioned such that the positioning member 140, a guidewire or otherinstrument (not shown) may slide or otherwise pass through the sealant2, as described elsewhere herein.

The sealant 2 may be substantially homogeneous or may include one ormore different materials at one or more locations. For example, in oneembodiment, the sealant 2 may include a carrier or core having first andsecond hydrogel precursors disposed thereon in an unreactive state,which may provide an adherent coating when the sealant 2 is exposed toan aqueous environment. In one embodiment, the sealant 2 may be formedfrom a biocompatible and/or bioabsorbable hydrogel, e.g., polyethyleneglycol (“PEG”), or other synthetic material. For example, the hydrogelmay include a lyophilized (i.e., freeze-dried) PEG polymer that includeshydrolytically degradable chemical groups, e.g., including a macroporouspolymer network, which may uptake fluid and expand when exposed to anaqueous environment. The magnitude of expansion or swelling (pre to posthydration) may be significant, e.g., between about two and ten times(2×-10×) its lyophilized size based on volume.

In addition or alternatively, the sealant 2 may include pro-thromboticmaterial, e.g., including one or more biological pro-thrombotics, suchas collagen, fibrin, carboxymethylcellulose, oxidized cellulose,alginates, gelatin, or other protein-based material, and/or syntheticmaterials, such as polyglycolic acids (PGA's), polyactides (PLA's),polyvinyl alcohol, and the like. Optionally, the sealant 2 may includeone or more therapeutic and/or pharmaceutical agents, e.g., to promotehealing, prevent infection, and/or other adverse medical events, and thelike. Such agents may be embedded in the sealant material and/or appliedas one or more coatings or layers. Exemplary materials and methods formaking and using them are disclosed in U.S. Pat. Nos. 6,152,943,6,165,201, 6,179,862, 6,514,534, 6,379,373, 6,703,047, 7,009,034,6,887,974, and in co-pending U.S. patent application Ser. No.10/454,362, filed Jun. 4, 2003, published as US 2004/0249342, Ser. No.10/982,387, filed Nov. 5, 2004, published as US 2006/0034930, Ser. No.10/982,384, filed Nov. 5, 2004, published as US 2006/0099238, and Ser.No. 11/465,791, filed Aug. 18, 2006 published as US 2007/0231366. Thedisclosures of these references are expressly incorporated by referenceherein.

The sealant 2 may be disposed within the lumen 126 of the cartridge 120proximate to the distal end 124, e.g., immediately adjacent the distaltip 125. Thus, when advanced into the introducer sheath 20 or otherwisewithin the puncture 90, the sealant 2 may remain out of direct orindirect contact with blood or other bodily fluids along the blood path.Optionally, the cartridge 120 may include a split distal end (notshown), e.g., formed by creating one or more relatively shortlongitudinal cuts or slots extending proximally from the distal end 124.The split distal end may facilitate retraction of the cartridge 120relative to the sealant 2, e.g., by providing extra flexibility at thedistal end 124, which may allow the distal end 124 to separate moreeasily from the sealant 2, e.g., as the sealant begins to expand uponbeing exposed to an aqueous environment, such as blood or other bodilyfluids. The lumen 126 may be sized such that the cartridge 120 andsealant 2 are slidable relative to one another, e.g., to allow thecartridge 120 to be refracted proximally relative to the sealant 2and/or pusher member 130.

With further reference to FIG. 1B, the pusher member 130 may be anelongate tubular body, e.g., a plunger or catheter, including a proximalend 132, a distal end 134 sized for introduction into the lumen 126 ofthe cartridge 120, and a lumen 136 extending between the proximal anddistal ends 132, 134. The pusher member 130 may be sized for beingslidably received within the lumen 126 of the cartridge 120, althoughthe pusher member 130 may abut or otherwise interact with the hub 123 ofthe cartridge 120 such that the pusher member 130 is advanced distallywhen the cartridge 120 is advanced distally. The distal end 134 of thepusher member 130 may terminate in a substantially blunt distal tip 135,e.g., to facilitate contacting, pushing, and/or “cinching” the sealant 2within a puncture, as described further below.

The pusher member 130 may be substantially rigid, semi-rigid, and/orsubstantially flexible, having sufficient column strength to allowproximal movement of the cartridge 120 relative to the sealant 2 withoutbuckling the pusher member 130 and/or to allow the distal tip 135 of thepusher member 130 to be “tamped” down on sealant 2 within a puncture,e.g., by pushing from the proximal end 132, as described elsewhereherein. The lumen 136 of the pusher member 130 may be sized toaccommodate the positioning member 140, a guidewire (not shown), aflowable sealing compound, and/or fluid therethrough.

With continued reference to FIGS. 1A, 1B, and 5 , the positioning member140 generally is an elongate member including a proximal end 142, adistal end 144, a positioning or occlusion element 146 on the distal end144, and a hollow cylinder or other housing 416 on the proximal end 142.The positioning element 146 may be an expandable member, such as aballoon, a wire mesh structure, an expandable frame, and the like. Thepositioning element 146 may be selectively expandable, e.g., using asource of inflation media, a pull wire, and/or other actuator (notshown), operable from the proximal end 142 of the positioning member140.

For example, as shown in FIGS. 1A and 1B, the positioning element may bea balloon 146, and the positioning member 140 may be a tubular bodyincluding a lumen (not shown) extending between the proximal and distalends 142, 144 and communicating with an interior of the balloon 146. Inthis embodiment, the cylinder 416 may include an inner chambercommunicating with the lumen and a source of inflation media. Forexample, a syringe (not shown) may be coupled to stop cock 149 suchthat, when the stop cock 149 is opened, the interior of the syringe maycommunicate with the chamber (and consequently the lumen and interior ofthe balloon 146) via tubing 147 connected to a port 417 on the cylinder416. Optionally, the positioning member 140 may include an internal pullwire and piston arrangement (not shown) that causes the balloon 146 toshorten during expansion and extend during collapse. Exemplaryembodiments of positioning members 140 including balloons that may beused are disclosed in co-pending U.S. patent application Ser. No.10/454,362, filed Jun. 4, 2003, published as US 2004/0249342, Ser. No.11/112,877, filed Apr. 22, 2005, published as US 2006/0253072, and Ser.No. 11/112,971, filed Apr. 22, 2005, and published as US 2008/0009794.The entire disclosures of these references are expressly incorporated byreference herein.

Alternatively, the positioning element may be biased to an enlargedcondition, but may be compressed to a contracted condition, e.g., by anoverlying sleeve or other constraint (not shown). The constraint may beremoved to expose the positioning element, allowing the expandableelement to automatically expand to the enlarged condition. Additionalinformation on expandable structures that may be provided on thepositioning member 140 may be found in U.S. Pat. Nos. 6,238,412,6,635,068, and 6,890,343. The entire disclosures of these references areexpressly incorporated herein by reference.

Turning to FIGS. 2A and 2B, the apparatus 101 may be used to positionand deliver the sealant 2 within a puncture, e.g., extra-vascularly justabove or otherwise adjacent to an arteriotomy in a blood vessel or otherbody lumen communicating with a puncture, as described further elsewhereherein. In one embodiment, as shown in FIG. 2A, the cartridge 120 (alongwith the pusher member 130 and sealant 2) may be initially provided onthe proximal end 142 of the positioning member 140. For example, thehousing 148 (not shown in FIGS. 2A and 2B, see FIG. 1A) on thepositioning member 140 and the hub 123 on the cartridge 120 mayinitially be connected to one another, e.g., using one or morereleasable detents (not shown) and the like. The cartridge 120 may beslidable distally along the positioning member 140, e.g., bydisconnecting the hub 123 from the housing 148, and then advancing thecartridge 120 until the distal end 124 of the cartridge 120 is disposedadjacent the positioning element 146, as shown in FIG. 2B. For example,the detents may simply separate from one another when the hub 123 isadvanced away from the housing 148 with sufficient force. Alternatively,one of the hub 123 and housing 148 may include an actuator or lock (notshown) that may be activated to separate the detents and/or otherwiseallow the cartridge 120 to be advanced relative to the positioningmember 140. Alternatively, the cartridge member 120 and pusher member130 may be initially provided adjacent the distal end 144 of thepositioning member 140, as shown in FIG. 2B.

Optionally, the positioning member 140 and/or pusher member 130 mayinclude one or more elements that engage when the cartridge 120 reachesa predetermined location when advanced distally along the positioningmember 140, e.g., to limit subsequent proximal movement of the pushermember 130 relative to the positioning member 140. For example, as shownin FIGS. 2A and 2B, the positioning member 140 may include a ring, tab,or other raised element 145 at a predetermined location and the pushermember 130 may include a living hinge, tab, or other latch element 137on the proximal end 132. For example, the latch element 137 may simplybe an annular notch in the proximal end 132 of the pusher member 130 tobias the proximal end inwardly.

As an alternative to the latch element(s) 137, the pusher member 130 maysimply include a relatively narrow region on the proximal end 132.Further alternatively, the latch element(s) 137 may be replaced by aseparate collar or sleeve, one or more inwardly oriented detents, andthe like (not shown) attached to or otherwise formed on the proximal end132 of the pusher member 130. As an alternative to the raised element145, the positioning member 140 may include a reduced diameter region(not shown) formed by providing a larger tube around a smaller innertube or by machining, etching, or otherwise removing a portion of thetubular body of the positioning member 140 distal to the reduced regionand the pusher member 130 may include a corresponding element (also notshown) that may allow distal advancement but prevent proximal retractiononce the pusher member 130 is advanced a predetermined distance.Exemplary embodiments of cooperating elements are disclosed inco-pending U.S. patent application Ser. No. 10/982,384, filed Nov. 5,2004, published as US 2006/0099238 and [Ser. No. 11/864,835, filed Sep.28, 2007. The entire disclosures of these references are expresslyincorporated by reference herein.

The reduced region (not shown) or raised element 145 may be provided ata predetermined location on the positioning member 140, e.g., apredetermined distance from the positioning element 146 that correspondsto a length of the pusher member 130. As the cartridge 120 (andconsequently the pusher member 130) is advanced over the positioningmember 140, e.g., until the sealant 2 is disposed adjacent thepositioning element 146, the latch element 137 may pass freely over theraised element 145. Thereafter, the latch element 137 may prevent thepusher member 130 from being retracted again past the raised element 145due to the blunt edge of the latch element 137 abutting the raisedelement 145.

Alternatively, the pusher member 130 may be fixed relative to thepositioning member 140, for example, mechanically bonded, chemicallybonded, interference fit, and the like. For example, the distal end 134of the pusher member 130 may be fixed a predetermined distance proximalto the positioning element 146, e.g., to provide the sealant 2immediately adjacent the positioning element 146, as shown in FIG. 2B.Additional information on such alternatives and methods for making andusing them may be found in co-pending U.S. patent application Ser. No.11/854,534, filed Sep. 12, 2007, the entire disclosure of which isexpressly incorporated by reference herein.

Optionally, the system 10 may include a locking member (not shown) forcoupling the introducer sheath 20 to the cartridge 120 during use suchthat subsequent movement of the cartridge 120, e.g., proximally duringretraction, causes the introducer sheath 20 to be pulled or otherwisemoved along with the cartridge 120. This coupling may prevent accidentalproximal movement of the cartridge 120 independent of the introducersheath 20, which may otherwise result in deploying the sealant 2 fromthe cartridge 120 within the introducer sheath 20, rather than within apuncture itself. Exemplary embodiments of locking elements that may beused are disclosed in co-pending U.S. patent application Ser. No.11/864,835, incorporated by reference above.

Turning to FIGS. 3A-5 , the housing 148 on the positioning member 140,shown in FIG. 1A, may include a tension indicator assembly 400, e.g.,provided around or otherwise carried by the cylinder 416. The tensionindicator assembly 400 may be configured to provide a visual cueindicating that a desired amount of tension is being applied by thepositioning member 140 during use. For example, during retraction of thepositioning member 140, the tension indicator assembly 140 may indicatewhen an optimum amount of tension is being applied against a vessel wallby the expanded positioning element 146 (shown in FIG. 5 ), e.g.,sufficient to seal the vessel from the puncture, as discussed in furtherdetail below.

The tension indicator assembly 400 may include a two-piece housing,including a proximal housing portion 148 a and a distal housing portion148 b, surrounding the cylinder 416. Optionally, the proximal housingportion 148 a may be shaped to provide a handle to facilitatemanipulating the positioning member 140 and/or to facilitate pulling theproximal housing portion 148 a away from the distal housing portion 148b during use. The distal housing portion 148 b may be substantiallyfixed relative to the cylinder 416, and the proximal housing portion 148a may be movable proximally away from or otherwise relative to thedistal housing portion 148 b (and consequently the cylinder 416 andother portions of the positioning member 140), yet biased to returntowards the distal housing portion 148 b.

As shown in FIGS. 3A-5 , each of the proximal and distal housingportions 148 a, 148 b may be formed from multiple components that areattached together, such as injection molded plastic covers or sleeves.For example, the proximal housing portion 148 a may include twohalf-covers that may be attached along opposing edges, e.g., using oneor more cooperating connectors, adhesives, sonic welding, fusing, andthe like. Similarly, the distal housing portion 148 b may also includetwo half-covers that may be attached together. The two half-covers forthe distal housing portion 148 b may include two half-cylindersextending therefrom that define a cylindrical sleeve 410 when thehalf-covers of the distal housing portion 148 b are attached together.Alternatively, the half-cylinders of the cylindrical sleeve 410 may beseparate components that are attached to the half-covers of the distalhousing portion 148 b, e.g., using one or more cooperating connectors(such as a semi-annular tab on the half-cylinders that may be receivedin corresponding semi-annular slots in the half-covers, not shown),adhesives, sonic welding, fusing, and the like. In this alternative, thehalf-cylinders of the cylindrical sleeve may be made from a materialthat contrasts with the material of the half-covers of the distalhousing portion, e.g., a contrasting color.

The cylindrical sleeve 410 may be sized such that the proximal housingportion 148 a may be slidably disposed around the cylindrical sleeve410, as described further below. Optionally, the cylindrical sleeve 410and/or proximal housing portion 148 a may include one or more featuresfor limiting movement of the proximal housing portion 148 a relative tothe cylinder 410 (and consequently relative to the distal housingportion 148 b). For example, as best seen in FIG. 5 , the cylindricalsleeve 410 may include a rail 412 or other track, e.g., a groove (notshown) and/or tab 414 integrally molded or otherwise formed with thecylindrical sleeve 410. A rail 412 and tab 414 may be provided on one orboth sides of the cylindrical sleeve 410 (the lower rail and tab notbeing visible in FIG. 5 ) The proximal housing portion 148 a may includea shoulder 408 contoured to slidably fit around the cylindrical sleeve410 and the shoulder 408 may include one or more slots 409 sized toslidably receive the respective rails 412 therein. Alternatively, theshoulder 408 may include one or more alternative features, e.g., tabs,grooves, and the like (not shown) corresponding to the track(s) on thecylindrical sleeve 410. For example, the rails 410 and slots 409 mayallow the proximal housing portion 148 a to slide substantially axiallyrelative to the cylindrical sleeve 410 and distal housing portion 148 bwithout substantial rotation around the cylindrical sleeve 410.

A spring or other biasing element 402 (see FIGS. 3B, 4B and 5 ) may becoupled to the proximal and distal housing portions 148 a, 148 b. Avisual cue may be provided by the space 404 created by the separation ofthe two housing portions 148 a, 148 b of the housing 148, as shown inFIGS. 4A and 4B. When tension is not applied, the spring 402 is in afirst position or relatively relaxed state, such as in a pre-loadedstate (e.g., where the spring 402 is slightly compressed). Pre-loadingthe spring 402 may provide a desired force to bias the proximal anddistal housing portions 148 a, 148 b together, as shown in FIGS. 3A and3B. The spring rate or constant of the spring 402 may be selected suchthat a force sufficient to compress the spring 402 to a desired extent(e.g., to substantially completely compress the spring 402) is slightlyless than a desired tension force applied by the positioning member 140during use, e.g., slightly less than the tension that would otherwisecause vessel tenting, as explained further below.

For example, when the desired amount of tension is applied between theproximal and distal ends 142, 144 of the positioning member 140, thespring 402 may compress, allowing the proximal and distal housingportions 148 a, 148 b to separate from one another, as shown in FIGS. 4Aand 4B. The space 404 between the proximal and distal housing portions148 a, 148 b that results when the spring 402 is compressed may serve asthe visual cue to the user that the desired amount of tension is beingapplied. Optionally, the exposed region within the space 404 may includeone or more colors, text, and/or other visual markers (not shown), e.g.,a contrasting color to the color of the housing portions 148 a, 148 b,that may enhance observation of the space 404 as the housing portions148 a, 148 b separate.

In the embodiment shown, the spring 402 is a compression spring that isinitially in a first position corresponding to a relatively relaxedstate (shown in FIGS. 3A and 3B), e.g., a pre-loaded state (with thecompressed length equal to the distance set by the spring retaining ring406 and the shoulder 408 of the proximal housing portion 148 a) and iscompressible to a higher potential energy state in a second, relativelycompressed position (shown in FIGS. 4A and 4B) when a load is applied.Alternatively, instead of the compression spring 402, the tensionindicator assembly 400 may include other spring arrangements or biasingmechanisms, such as an extension spring, leaf spring, coil spring, andthe like (not shown), e.g., that may be in a lower potential energystate when the proximal and distal housing portions 148 a, 148 b contactor are closer to one another and in higher potential energy state when aload is applied to separate or otherwise move the proximal and distalhousing portions 148 a, 148 b away from one another.

As shown in FIGS. 3A-5 , the spring 402 of the tension indicatorassembly 400 is disposed in the proximal housing portion 148 a between aspring retaining ring 406 and the shoulder 408 of the proximal housingportion 148 a. The spring 402 surrounds the cylinder 416 and cylinder410, and the spring retaining ring 406 is fixedly attached to thecylindrical sleeve 410 so that a proximal end 402 a of the spring 402 isessentially stationary relative to the cylindrical sleeve 410 and adistal end 402 b of the spring 402 is free to move along the cylindricalsleeve towards the proximal end 402 a of the spring 402. For example,the spring retaining ring 406 may include a slot 422 that receives thetab 414 on the cylindrical sleeve 410, thereby attaching the springretaining ring 406 to the cylindrical sleeve 410 during assembly. Thedistal housing portion 148 b is fixedly coupled to the cylinder 416 sothat when the proximal housing portion 148 a is separated or otherwiseproximally refracted away from the distal housing portion 148 b, i.e.,when the spring bias is overcome, the distal housing portion 148 b andthe cylinder 416 remain substantially stationary relative to oneanother, thereby causing the separation of the proximal housing portion148 a and the distal housing portion 148 b.

The distal housing portion 148 b may be attached to the cylinder 416 inany manner. In the embodiment shown in FIGS. 3A-5 , the distal housingportion 148 b includes a cavity or recess sized to receive the cylinder416 therein, e.g., such that the port 417 prevents relative axial and/orrotational movement of the cylinder 416 relative to the distal housingportion 148 b. Optionally, the port 417 may extend through an opening inthe distal housing portion 148 b, as shown in FIGS. 3A and 3B, therebyfurther fixing the cylinder 416 relative to the distal housing portion148 b. Alternatively or in addition, the cylinder 416 may be attached tothe cylindrical sleeve 410 and/or other components of the distal housingportion 148 b, e.g., by bonding with adhesive, interference fit, sonicwelding, cooperating connectors, and the like.

With continued reference to FIGS. 3A-5 , to make the tension indicatorassembly 400, the components are made, e.g., as described above, andassembled together. For example, the components of the distal housingportion 148 b may be attached together around the cylinder 416. Thespring 402 may then be disposed around the cylindrical sleeve 410, andthe spring retaining ring 406 may be slid over the cylinder 416 and thenover the cylindrical sleeve 410 until the tab(s) 414 on the cylindricalsleeve 410 are captured in the slot(s) 422 in the spring retaining ring406. Alternatively, the cylindrical sleeve 410 and/or spring retainingring may be integrally molded or otherwise formed as part of thecylinder 416.

The components of the proximal housing portion 148 a are then attachedtogether around the cylinder 416 and cylindrical sleeve 410, e.g., suchthat the cylindrical sleeve 410 is encircled by the shoulder 408 of theproximal housing portion 148 a and the hollow cylinder 410 extends intothe proximal housing portion 148 a when the spring 402 is in therelatively relaxed state. As described above, the proximal housingportion 148 a, including the shoulder 408 and any other components, maybe integrally molded or otherwise formed, e.g., as halves that may beattached together and/or slidably attached around the cylinder 416.Thus, the hollow cylinder 410 and the cylinder 416 coupled thereto areconfigured to slide in and out of the proximal housing portion 148 athrough an opening created by the shoulder 408 while the spring 402remains within the proximal housing portion 148 a between the shoulder408 and the spring retaining ring 406.

Turning to FIGS. 6A-10B, an exemplary method is shown for sealing apuncture 90, e.g., using the system 10 described above to deliver asealant 2, e.g., to achieve hemostasis within the puncture 90.Generally, the puncture 90 extends from a patient's skin 92 throughintervening tissue 96, e.g., to a body lumen 94. In an exemplaryembodiment, the puncture 90 may be a percutaneous puncture communicatingwith a blood vessel 94, such as a femoral artery, carotid artery, andthe like.

In an exemplary method, the puncture 90 may be created using knownprocedures, e.g., using a needle, guidewire, one or more dilators, andthe like (not shown). Then, as depicted in FIGS. 6A and 6B, anintroducer sheath 20 may be advanced through the puncture 90 into thevessel 94, e.g., over a guide wire (not shown) placed through thepuncture 90 into the vessel 94. The introducer sheath 20 may provideaccess into the vessel 94 for one or more instruments, e.g., to allowone or more diagnostic and/or interventional procedures to be performedvia the vessel 94. Upon completing the procedure(s) via the vessel 94,any such instrument(s) may be removed from the puncture 90, leaving theintroducer sheath 20 extending through the puncture 90 into the vessel94.

The distal end 144 of the positioning member 140 may be introduced intothe puncture 90, e.g., through the lumen 26 of the introducer sheath 20,with the expandable positioning element 146 in a collapsed condition, asshown in FIG. 6B. As shown in FIG. 6A, the cartridge 120, along with thesealant 2 and pusher member 130 (not shown in FIG. 6A for clarity, seeFIGS. 1A-2B), may be provided initially on the proximal end of thepositioning member 140, e.g. near the positioning member housing 148.Thus, the distal end 124 of the cartridge 120 may initially be locatedoutside the puncture 90 when the positioning member 140 is advanced intothe puncture 90. Alternatively, the cartridge 120 may be carried on thedistal end 144 of the positioning member 140, e.g., as shown in FIG. 2B,such that the cartridge 120 (along with the sealant 2 and pusher member130) are introduced simultaneously with the positioning member 140, asdescribed in co-pending U.S. patent application Ser. No. 11/854,534,incorporated by reference herein.

Still referring to FIGS. 6A and 6B, the distal end 144 of thepositioning member 140 may be inserted through the puncture 90 (via theintroducer sheath 20) and into the vessel 94. Optionally, thepositioning member 140 may include one or more markers (not shown) thatmay be disposed adjacent the proximal end 22 of the introducer sheath 20when the distal end 144 extends beyond the distal end 24 of theintroducer sheath 20. Once the positioning element 146 is disposedwithin the vessel 94, i.e., beyond the distal end 24 of the introducersheath 20, the positioning element 146 may be expanded to an enlargedcondition, as shown in FIG. 6A and as shown in phantom in FIG. 6B. Afterexpanding the positioning element 146, the positioning member 140 may beat least partially withdrawn until the positioning element 146 contactsthe wall of the vessel 94, e.g., to substantially seal the vessel 94from the puncture 90.

In an exemplary method, this may involve a two-step process (although itmay be completed in a single, substantially continuous action). First,with the positioning element 146 expanded within the vessel 94, as shownin FIG. 6A and in phantom in FIG. 6B, the positioning member 140 may bewithdrawn until the positioning element 146 contacts the distal end 24of the introducer sheath 20, which may provide a first tactile feedbackto the user (i.e., that the positioning element 146 has contacted theintroducer sheath 20, e.g., based upon the increased weight and/orresistance to proximal movement). After encountering the first tactilefeedback, the positioning member 140 may be withdrawn further until thepositioning element 146 contacts the wall of the vessel 94 and resistsfurther withdrawal, thereby providing a second tactile feedback. Theintroducer sheath 20 may be pulled proximally by the positioning element146 as the positioning member 140 is withdrawn, e.g., until thepositioning element 146 contacts the wall of the vessel 94 and thedistal end 24 of the introducer sheath 20 is withdrawn from the vessel94 into the puncture 90, as shown in FIGS. 7A and 7B.

The tension indicator apparatus 400 may facilitate confirming thatexcessive force is not applied by the positioning element 146 to thevessel 94, e.g., by identifying that an optimal amount of tension isbeing applied by the positioning member 140, e.g., during deployment ofthe sealant 2. For example, if the positioning member 140 is withdrawnwith excessive force after the positioning element 146 contacts the wallof the vessel 94, the wall of the vessel 94 may tent, which may causedamage to the wall of the vessel 94, and/or may cause ineffective orinaccurate sealing of the vessel 94. Conversely, if too little tensionis applied, the vessel 94 may not be properly sealed from the puncture90 and/or the sealant 2 may be deployed improperly, e.g., into thevessel 94. It may be desirable to provide additional indicators to theuser in addition to using the first and second tactile feedback duringwithdrawal of the positioning member 140 because detection of thefeedback depends on the tactile sensitivity of the user, which may beinaccurate.

Thus, the tension indicator assembly 400 may provide more accuratetension control, which may be calibrated by setting the spring constantof the spring 402 (not shown, see, e.g., FIG. 5 ). The desired amount oftension applied by the positioning member 140 may ensure that there issufficient force between the positioning element 146 and the wall of thevessel 94 to substantially seal the vessel 94, e.g., while avoidingtenting, and/or facilitating proper positioning of the sealant 2. Theforce corresponding to the desired tension may be slightly greater thanthe force required to compress the spring 402 in the tension indicatorassembly 400. During proximal retraction of the positioning member 140,the proximal housing portion 148 a separates from the distal housingportion 148 b when the desired amount of tension on the positioningmember 140 is achieved. Thus, the separation of the proximal and distalhousing portions 148 a, 148 b may indicate that proximal retraction ofthe positioning member 140 should be maintained at that force and notincreased, since further retraction may cause tenting of the vessel 94.The space 404 between the proximal and distal housing portions 148 a,148 b and/or appearance of the cylindrical sleeve 410 may serve as avisual cue that the desired amount of proximal tension is being appliedto the positioning member 140, e.g., for accurate deployment of thesealant 2. The desired amount of proximal tension may be maintainedmanually or using a tension device (not shown) to provide temporaryhemostasis, e.g., during the subsequent steps. Exemplary tension devicesare disclosed in co-pending U.S. patent application Ser. No. 10/806,952,filed Mar. 22, 2004 and published as US 2004/0267308, the entiredisclosure of which is expressly incorporated herein by reference.

Thus, as shown in FIG. 7A, the positioning member 140 has beenproximally retracted by pulling on the proximal housing portion 148 a,as indicated by arrow 162, until separation between the proximal anddistal housing portions 148 a, 148 b occurs, indicating that a desiredamount of proximal tension is being applied to the positioning member140 to accurately seal the vessel 94 from the puncture 90.

Turning to FIGS. 8A and 8B, the cartridge 120 (carrying the sealant 2,shown in FIG. 8B) may then be advanced distally over the positioningmember 140 into the puncture 90, as indicated by arrow 164. For example,FIG. 8A illustrates the cartridge 120 being advanced distally over thepositioning member 140 and into the introducer sheath 20. The cartridge120 may be further advanced into the introducer sheath 20 until thedistal end 124 of the cartridge 120 contacts the positioning element146, as shown in FIG. 8B.

In one embodiment, the cartridge 120 (and sealant 2) may be advancedthrough the introducer sheath 20 until a hub 123 of the cartridge 120abuts a hub 23 on the introducer sheath 20. In another embodiment, thecartridge 120 may be advanced until a locking element (not shown)engages, thereby coupling the cartridge 120 to the introducer sheath 20.

Once the sealant 2 is in the desired position within the puncture 90(shown in FIG. 8B), the housing 148 may be released (shown in FIG. 9A),causing the spring 402 (not shown in FIG. 9A for clarity, see FIGS. 3B,4B and 5 ) to return to its first position, i.e., pre-loaded, relativelyrelaxed state, thereby forcing the proximal and distal housing portions148 a, 148 b together. The cartridge 120 may be retracted, e.g., bypulling proximally on the hub 23 of the sheath 20 and/or the hub 123 ofthe cartridge 120, as indicated by arrow 165 in FIG. 9A. For example, ifthe optional locking element (not shown) has coupled the introducersheath 20 to the cartridge 120, pulling the hub 123 also withdraws theintroducer sheath 20 from the puncture 90. Alternatively, the introducersheath 20 may be pulled, thereby withdrawing the cartridge 120 alongwith the introducer sheath 20. As the cartridge 120 is retracted, thepusher member 130 may prevent substantial proximal movement of thesealant 2, thereby exposing the sealant 2 within the puncture 90, asshown in FIG. 9B. For example, as described above with reference toFIGS. 2A and 2B, as the cartridge 120 is advanced, the pusher member 130may pass over the raised element 145 of the positioning member 140, asshown in FIG. 2B. When the cartridge 120 is then retracted, the latchelement 137 on the pusher member 130 may abut the raised element 145,thereby preventing substantial proximal movement of the pusher member130 and the sealant 2 adjacent the distal end 134 of the pusher member130.

When the sealant 2 is exposed within the puncture 90, the sealant 2 maybe exposed to blood and/or other body fluids within the puncture 90.This exposure may cause the sealant 2 to absorb fluid and/or otherwiseexpand within the puncture 90, e.g., to provide hemostasis. If desired,once the sealant 2 is exposed within the puncture 90, the pusher member130 may be advanced to compress or tamp the sealant 2, e.g., against thepositioning element 146, as depicted by arrow 166 in FIG. 10A.Optionally, the positioning member 140 may include one or more distancemarkers 143 adjacent the proximal end 132 (after the cartridge 120 andpusher member 130 are advanced), and the pusher member 130 may beadvanced into the puncture 90 a desired distance, which may be confirmedby monitoring the distance markers 143. Optionally, during tamping, theproximal housing portion 148 a may be pulled until the proximal housingportion 148 a separates from the distal housing portion 148 b tomaintain the seal between the positioning element 146 and the wall ofthe vessel 94 while the sealant 2 is compressed.

Once the sealant 2 has been exposed for sufficient time and/or tamped bythe pusher member 130, the positioning element 146 may be collapsed, andthe positioning member 140 withdrawn from the vessel 94 and puncture 90,e.g., by pulling the collapsed positioning element 146 through thesealant 2 and pusher member 130. The pusher member 130 may be maintainedsubstantially stationary during withdrawal of the positioning member140, e.g., to prevent migration and/or dislodgment of the sealant 2within the puncture 90. Once the positioning member 140 is completelyremoved, the pusher member 130 may be removed from the puncture 90,leaving the sealant 2 within the puncture 90, as shown in FIG. 10B.

Optionally, after removing the positioning member 140, liquid hydrogelor other sealing compound, or other material may be delivered into thepuncture 90, e.g., above and/or around the sealant 2, to assist inachieving hemostasis. For example, such material may be delivered viathe lumen 136 of the pusher member 130 and/or by introducing anotherdelivery device (not shown) into the puncture 90, e.g., after removingthe pusher member 130. In another alternative, the cartridge 120 andsealant 2 may be eliminated, and the positioning member 140 may be usedto substantially seal the puncture 90 from the vessel 94 temporarily. Inthis alternative, other sealants may then be delivered into the puncture90, if desired, whereupon the positioning member 140 may be removed, asdescribed above.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

We claim:
 1. A method for sealing a puncture extending through tissue toa body lumen, comprising: introducing a distal end of an elongate memberthrough the puncture until a positioning element on the distal end isdisposed within the body lumen; introducing a tubular membersimultaneously with the elongate member, the tubular member comprising alumen through which the elongate member is positioned and a sealantpositioned within the tubular member at a distal end thereof proximatethe positioning element; deploying the positioning element within thebody lumen; retracting the elongate member until the deployedpositioning element contacts a wall of the body lumen adjacent thepuncture and a tension indicator indicates that a desired tension isbeing applied by the positioning element to the wall of the body lumen;and retracting the tubular member at least partially from the punctureto expose at least a portion of the sealant within the puncture distallybeyond the tubular member.
 2. The method of claim 1, wherein thepositioning element is an expandable balloon.
 3. The method of claim 1,further comprising: introducing an introducer sheath into the punctureprior to introducing the distal end of the elongate member through thepuncture; and, wherein the distal end of the elongate member isintroduced through the puncture by introducing the distal end of theelongate member through the introducer sheath.
 4. The method of claim 1,wherein retracting the tubular member further comprises holding thesealant proximate the positioning element with a pusher memberpositioned within the tubular member.
 5. The method of claim 4, furthercomprising advancing the pusher member toward the positioning element tocompress the sealant at least partially within the puncture.
 6. Themethod of claim 5, further comprising: collapsing the positioningelement; and, removing the positioning element from the puncture,thereby withdrawing the collapsed positioning element through thesealant.
 7. The method of claim 1, wherein retracting the positioningelement further comprises separating a first housing portion of thetension indicator from a second housing portion of the tensionindicator.
 8. The method of claim 7, wherein the first housing portionof the tension indicator is a proximal housing portion of the tensionindicator and wherein the second housing portion of the tensionindicator is a distal housing portion of the tension indicator.
 9. Themethod of claim 7, wherein the first housing portion of the tensionindicator is fixed to a proximal end of the positioning element.
 10. Themethod of claim 7, wherein the tension indicator comprises a spring, andwherein separating the first housing portion of the tension indicatorfrom the second housing portion of the tension indicator furthercomprises overcoming a biasing force of the spring.
 11. The method ofclaim 1, wherein the tension indicator indicates that sufficient contactforce is being applied to the wall of the body lumen by the deployedpositioning element to seal the body lumen from the puncture.
 12. Themethod of claim 1, wherein the tension indicator provides a visual cuethat a predetermined contact force is being applied to the wall of thebody lumen by the deployed positioning element.
 13. The method of claim12, wherein the visual cue includes at least one color, text or othervisual marker.
 14. The method of claim 1, further comprising: collapsingthe positioning element; and, removing the positioning element from thepuncture, thereby withdrawing the collapsed positioning element throughthe sealant.
 15. The method of claim 1, wherein the tubular member isadvanced until the sealant is disposed adjacent the positioning element,the method further comprising releasing the tension on the tensionindicator before retracting the tubular member to expose the sealantwithin the puncture.
 16. The method of claim 1, wherein the tubularmember is advanced until the sealant is disposed adjacent thepositioning element, the method further comprising maintaining thetension on the tension indicator before retracting the tubular member toexpose the sealant within the puncture.
 17. A method for sealing apuncture extending through tissue to a body lumen, comprising:introducing a distal end of an elongate member through the punctureuntil a positioning element on the distal end is disposed within thebody lumen; deploying the positioning element within the body lumen; andretracting the elongate member until the deployed positioning elementcontacts a wall of the body lumen adjacent the puncture and a tensionindicator indicates that a desired tension is being applied by thepositioning element to the wall of the body lumen, wherein retractingthe positioning element further comprises separating a first housingportion of the tension indicator from a second housing portion of thetension indicator.
 18. The method of claim 17, wherein the first housingportion of the tension indicator is a proximal housing portion of thetension indicator and wherein the second housing portion of the tensionindicator is a distal housing portion of the tension indicator.
 19. Themethod of claim 17, wherein the first housing portion of the tensionindicator is fixed to a proximal end of the positioning element.
 20. Themethod of claim 17, wherein the tension indicator comprises a spring,and wherein separating the first housing portion of the tensionindicator from the second housing portion of the tension indicatorfurther comprises overcoming a biasing force of the spring.
 21. A methodfor sealing a puncture extending through tissue to a body lumen,comprising: introducing a distal end of an elongate member through thepuncture until a positioning element on the distal end is disposedwithin the body lumen; deploying the positioning element within the bodylumen; retracting the elongate member until the deployed positioningelement contacts a wall of the body lumen adjacent the puncture and atension indicator indicates that a desired tension is being applied bythe positioning element to the wall of the body lumen; advancing atubular member carrying a sealant along the elongate member and throughthe introducer sheath; and, retracting the tubular member and theintroducer sheath at least partially from the puncture to expose atleast a portion of the sealant within the puncture distally beyond theintroducer sheath.
 22. The method of claim 21, further comprising:collapsing the positioning element; and, removing the positioningelement from the puncture, thereby withdrawing the collapsed positioningelement through the sealant.
 23. The method of claim 21, wherein thetubular member is advanced until the sealant is disposed adjacent thepositioning element, the method further comprising releasing the tensionon the tension indicator before retracting the tubular member to exposethe sealant within the puncture.
 24. The method of claim 21, wherein thetubular member is advanced until the sealant is disposed adjacent thepositioning element, the method further comprising maintaining thetension on the tension indicator before retracting the tubular member toexpose the sealant within the puncture.